Mod 5 fb53419ef094424fa25ad3d37976ab7c.pdf

🔏 Mod 5 Definitions what is statute written law adopted by a legislative body that governs a city country state or country Regulation rules issued by administrative agencies that have force of law Standard a uniform method of defining basic parameters for processes product services and measuremen...

🔏 Mod 5 Definitions what is statute written law adopted by a legislative body that governs a city country state or country Regulation rules issued by administrative agencies that have force of law Standard a uniform method of defining basic parameters for processes product services and measurements regulatory stanards a comparison benchmark that is mandated by governing agency noncompliance with regulatory standards may lead to citations and legal penalties ‫بتتعاقب لو ما سويته‬ Mod 5 1 voluntary standards guidelines or recommendations for best practices to provide better patient care industry nonprofit organization trade association and other develop best practice a method or technique that has consistently shown result superior to those achieved by other means aa Medical Classification and Agencies what is mean of FDA and what type of agency it is FDA is food And Drug administration and its federal agency What is FDA responsible for FDA is responsible for ensuring that food cosmetic human and veterinary drugs biological product that emit radiation are safe and effective for public use FDA is classified Medical device to what ? FDA is classified Medical device to 3 Class Class 1 these include low risk device Class 2 these devices are considered to pose potential risk great enough warrant a higher level of regulation Class 3 these are the most stringently regulated device and include heart valves PHOTO#$#$ Mod 5 2 Recall Medical device recall is the process of recollecting products due to malfunction or patient harm and the manufacturers; distributors or the end-users can carry it. The FDA monitors all the products that are mandated for recall in order to protect the public. FDA classifies product recall into three categories: Mod 5 3 what is SFDA Saudi Food and Drug Administration SFDA/ U.S Food and Drug Administration The Saudi Food and Drug Administration is a governmental regulatory body it was established in 2003 and it directly reports to the President of Council of Ministers. what is the aims for SFDA is to regulate 1. The safety of food and drugs for human and animal. 2. The safety of biological and chemical substance. 3. The safety of electronic devices that related to human health. 4. The accuracy and safety of medical and diagnostic devices. 5. The control and supervise licenses procedures for food, drugs and medical devices factories. 6. The disseminate and exchange information with local and international scientific and legal agencies, and setting up a database for food and drug. Mod 5 4 What it the meaning of DOT DOT is US department of transportation what is DOT Its Federal government agency dedicated to ensuring A fast safe and efficient transportation system laws relating to health care including those concetning the transportation of minimally processed instrumentation for repair or reprocessing and the transportation of hazardous and radioactive waste The DOT inspects and cites organization for statute violation CDC Centers for Disease Control It is a federal agency within the department of Health and Human Services in USA. The aim of the agency is to promote the wellbeing and prevent injuries, diseases and disabilities. CSSD professionals are in charge of developing infection control and prevention guidelines and isolation techniques. Although CDC is not a regulatory body, majority of healthcare organizations incorporate the CDC recommendations in their policy and procedures. what is US environmental protection agency Regulatory agency the purpose of protecting human health and the environment by writing and enforcing EPA Responsible for Minimizing greenhouse gases and toxic details The USA congress developed the EPA department in 1970 as a regulating agency that protects human health and the environment. The aim of the agency is to reduce the greenhouse gases and toxic emissions, control indoor air pollution, create, and reinforce pesticide regulations. In the Kingdome of Saudi Arabia, the Ministry of Environment, Water and Agriculture is the national agency that provides the environmental and water regulations for healthcare organization. Mod 5 5 The goal is to maintain optimum human health and to reduce the greenhouse gasses for the environment protection. Moreover, the ministry cooperates with other ministers and authorities to create and implement national guidelines that aims to protect and minimizes environmental, water pollution and response to environmental emergencies. Greenhouse gasses are defined as gasses that absorb solar radiation such as carbon dioxide, methane, ozone and fluorocarbons. What is Occupational safety and health Administration its primary role and responsibilty is to protcet worker from occupational caused illnesses and injuries Details The OSHA organization was developed in 1971 under the U.S. Department of Labor. Its main objective is to protect all kind of workers from occupation associated injuries and illnesses. Many of the OSHA regulations and guidelines are incorporated into the Saudi Labor Law. CSSD professionals must be aware of the OSHA regulations that pertaining to their practices. Guidelines and standards of OSHA related to the CSSD are: • The Occupational Exposure to Blood-borne Pathogens standards • Guidelines for the use of Ethylene Oxide Sterilization • The General Duty Clause of the Occupational Safety and Health Act Professional association what is the job for Professional association its develop and promote voluntary standards that provide a foundation for processes and practices pefromed in the CSSD function Mod 5 6 Healthcare Agencies and Associations Healthcare agencies and associations create and promote voluntary guidelines and standers that can be provide the fundamental process and practices of the CSSD professionals. CSSD professionals are required to be aware of theses agencies and their standards. AAMI Association for the advancement of medical instrumentation (AAMI) Voluntary guidelines representing a consensus of AAMI members that are intended for use by healthcare facilities manufacturers to help ensure that medical instrument is safe for patient use Detailes The AAMI was established in 1967, its nonprofit organization that comprised of multidisciplinary healthcare professional from technicians, engineers, scientists and members of other organizations such as FDA. The aims is to develop a Technical Information Reports (TIR) that are address the following: • To develop, manage and the utilization of safe and effected reusable medical devices • To address the proper care and reprocessing of reusable medical devices. • To develop standards related to medical products labeling and performance requirement. Although the standards from the AAMI are voluntary and not mandatory they are considered critical elements in the CSSD practices, therefore CSSD personal must be familiar with the AAMI guidelines and the new updates american national standards institute (ANSI) The ANSI institution was established in 1918 with a mission “To enhance both the global competitiveness of U.S. business and the U.S. quality of life by promoting and facilitating voluntary consensus standards and conformity assessment systems, and safeguarding their integrity”. American National Standards Institute is the only U.S.A representative to the International Standards Organization (ISO). Mod 5 7 Association of Operating Room Nurses or Association of periOperative Registered Nurses(AORN) Association of Operating Room Nurses (AORN) is a professional organization that consists of Registered Nurses in the specialty of the Perioperative Care and other professionals with an aim to enhance patient care related to surgery. The AORN standards are reprinted annually and reviewed every five years. Association for Professionals in Infection Central and Epidemiology (APIC) It’s an international organization that voluntarily provides guidelines related to infection prevention and control in order to prevent Hospital Acquired Infection (HAI) in the healthcare organizations. The Infection Prevention and Control Department can conduct CSSD departmental surveys annually depending on the organization’s policy. Examples of the APIC guidelines are: • Bioterrorist Readiness Plan. • Guidelines for Infection Prevention. • Control in Flexible Endoscope International Standards Organization (ISO) The ISO is considered as non-governmental organization with national standards representing more than 163 countries. The standards from the ISO give specifications related to products, service or practice. Although that ISO provides a voluntary standers most of these standards are adopted and enforced by many countries. Moreover, the ISO standers in regards to the CSSD are submitted by the AAMI organization therefore it’s a trend by the healthcare organizations internationally to become ISO- Certified in the field of CSSD. the joint commission national fire protection association united state pharmacopoeia national formulary society of gastroenterology nurses and associates (SGNA) Society of Gastroenterology Nurses and Associates is non-profit organization that develops voluntarily guidelines to assure safe and effective practice of the gastroenterology and the endoscopy nursing services. Moreover, the organization develops and reviews guidelines related to reprocessing flexible endoscopes. Mod 5 8 Examples of the SGNA guidelines are: •• Guidelines for the Use of High Level Disinfectants and Sterilization for Reprocessing of Flexible Gastrointestinal Endoscope •• Standard of infection Control in Reprocessing of Flexible Gastrointestinal Endoscope. Canadian standard association European committee for standardisation Mod 5 9